- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02901691
RHYTHMIC STIMULUS EFFECTS ON NEURONAL OSCILLATORY ACTIVITY AND SPEACHES CAPABILITIES IN DEAF CHILDREN
The deaf children showed deficits in speech processing and temporality. They badly apprehend temporal concepts and perceptions of deficit so the acoustic phenomena marking the time course linguistically. Their prediction capabilities and anticipation multisensory events are thereby affected, thus impacting their ability to adapt to multiple and complex interaction possibilities that arise during a conversation.The project aim it is to measure the impact of a musical rhythmic stimulation of neuronal activity and the temporal prediction capabilities of older deaf children 5 to 8 years and its impact on their language skills in a conversational task. A matched control group of age will be examined for each of the proposed tasks.
We first measure the capacity to anticipate a situation of language interaction. For this purpose, we will use an alternate naming paradigm with a virtual partner, already developed and tested in children with normal hearing. This paradigm approaches the conversational situation while allowing control of the time parameter of speech (speed of trade) and by controlling the bias (temporal) inherent linguistic programming difficulties of children in a spontaneous conversation situations .
Then we will couple behavioral measurements with measurements of eye movements and the electroencephalogram (EEG) in deaf children. For this, we use a dialog observation task already developed for normal hearing children. This task will allow us firstly to analyze the anticipation level of speaking turns by analyzing eye movements (which "precedes" the speaker). Secondly, it will allow us to study the effects of manipulation of the acoustic parameters of auditory evoked potentials (AEP) and the oscillatory activity of the motor system (EEG, mu rhythm and beta). The audiomoteur coupling would seem to be the key point of anticipatory processes and convergence in conversational interaction will also be studied using cortico-cortical coherence techniques to assess the dynamics of connectivity between remote networks (system here auditory and motor system).
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Marseille, France, 13354
- Recruiting
- Assistance Publique Hôpitaux de Marseille
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Contact:
- Stéphane ROMAN, MD
- Email: stephane.roman@ap-hm.fr
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- prélingual paired deaf or implanted cochlear children.
Exclusion Criteria:
- Childreen with other major disabilities and associated disorders.
- Clidren with failure to understand instructions either directly oral or sign language.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Experimental: Deaf children
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Placebo Comparator: healthy volonteer children
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Numbers of words and phrases productions in the hearing impaired child.
Time Frame: 3 months
|
3 months
|
Collaborators and Investigators
Investigators
- Principal Investigator: Stéphane ROMAN, MD, Assistance Publique Hôpitaux de Marseille
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2015-31
- 2015-A01490-49 (Other Identifier: Ansm)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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